Trial · NCT03094416

Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

NCT03094416, Phase 4, Completed, IBSA Institut Biochimique SA; results first posted 2022-04-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors. Trials, record NCT03094416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03094416

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors
NCT number: NCT03094416
Status: Completed
Phases: Phase 4
Enrollment: 66 participants, actual
Lead sponsor: IBSA Institut Biochimique SA
Conditions: Hypothyroidism;Postablative
Interventions: levothyroxine sodium capsule, Proton pump inhibitor (PPI), Levothyroxine Sodium (LT4) Tablets
First posted: 2017-03-29
Last updated: 2022-04-05
Results first posted: 2022-04-05
Limitations and caveats: Due to Covid-19 pandemic outbreak leading to discontinuation of subjects, primary endpoint was assessed on 43 subjects instead of 48 subjects (as planned in the sample size calculation). The a-posteriori study power is 91%.

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Thyroid Stimulating Hormone (TSH)	baseline and 12 weeks	Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline
Secondary	Free Thyroxine (FT4)	baseline and 12 weeks	Change in Serum Levels of FT4 (free thyroxine) from Baseline
Secondary	Total Thyroxine (TT4)	baseline and 12 weeks	Change in Serum Levels of TT4 (total thyroxine) from Baseline
Secondary	Free Triiodothyronine (FT3)	baseline and 12 weeks	Change in Serum Levels of FT3 (free triiodothyronine) from Baseline
Secondary	Total Triiodothyronine (TT3)	baseline and 12 weeks	Change in Serum Levels of TT3 (total triiodothyronine) from Baseline
Other	Creatine Phosphokinase (CPK)	baseline and 12 weeks	Change in Serum Levels of creatine phosphokinase (CPK) from Baseline
Other	Sex Hormone Binding Globulin (SHBG)	baseline and 12 weeks	Change in Serum Levels of SHBG (sex hormone binding globuline) from Baseline
Other	Ferritin	baseline and 12 weeks	Change in Serum Levels of ferritin from Baseline
Other	Angiotensin Converting Enzyme (ACE)	baseline and 12 weeks	Change in Serum Levels of ACE (angiotensin converting enzyme) from Baseline
Other	Triglycerides	baseline and 12 weeks	Change in triglycerides levels from Baseline

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Thyroid Stimulating Hormone (TSH)	baseline and 12 weeks	intention to treat (ITT), 4 subjects not considered in the analysis because of drop-out or LT4 dose change	mIU/L	MEAN
SECONDARY	Free Thyroxine (FT4)	baseline and 12 weeks	ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change	pmol/L	MEAN
SECONDARY	Total Thyroxine (TT4)	baseline and 12 weeks	ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change	nmol/L	MEAN
SECONDARY	Free Triiodothyronine (FT3)	baseline and 12 weeks	ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change	pmol/L	MEAN
SECONDARY	Total Triiodothyronine (TT3)	baseline and 12 weeks	ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change	nmol/L	MEAN
OTHER_PRE_SPECIFIED	Creatine Phosphokinase (CPK)	baseline and 12 weeks	ITT, 6 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed	U/L	MEAN
OTHER_PRE_SPECIFIED	Sex Hormone Binding Globulin (SHBG)	baseline and 12 weeks	ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change	nmol/L	MEAN
OTHER_PRE_SPECIFIED	Ferritin	baseline and 12 weeks	ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change	mcg/L	MEAN
OTHER_PRE_SPECIFIED	Angiotensin Converting Enzyme (ACE)	baseline and 12 weeks	ITT, 9 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed	U/L	MEAN
OTHER_PRE_SPECIFIED	Triglycerides	baseline and 12 weeks	ITT, 7 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed	mmol/L	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Thyroid Stimulating Hormone (TSH)	Tirosint Capsules	-0.676	Standard Deviation 1.3181	mIU/L
Free Thyroxine (FT4)	Tirosint Capsules	0.593	Standard Deviation 2.7439	pmol/L
Total Thyroxine (TT4)	Tirosint Capsules	2.558	Standard Deviation 27.2426	nmol/L
Free Triiodothyronine (FT3)	Tirosint Capsules	0.263	Standard Deviation 0.5716	pmol/L
Total Triiodothyronine (TT3)	Tirosint Capsules	0.098	Standard Deviation 0.3158	nmol/L
Creatine Phosphokinase (CPK)	Tirosint Capsules	-35.073	Standard Deviation 125.1454	U/L
Sex Hormone Binding Globulin (SHBG)	Tirosint Capsules	0.884	Standard Deviation 19.1861	nmol/L
Ferritin	Tirosint Capsules	-6.442	Standard Deviation 30.2390	mcg/L
Angiotensin Converting Enzyme (ACE)	Tirosint Capsules	-0.395	Standard Deviation 11.6237	U/L
Triglycerides	Tirosint Capsules	0.075	Standard Deviation 0.5419	mmol/L

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Run-in	STARTED	Tirosint Capsules	66
Run-in	COMPLETED	Tirosint Capsules	47
Run-in	NOT COMPLETED	Tirosint Capsules	19
Treatment Period	STARTED	Tirosint Capsules	47
Treatment Period	COMPLETED	Tirosint Capsules	45
Treatment Period	NOT COMPLETED	Tirosint Capsules	2

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Treatment Period: Tirosint Capsules	2	47	2
other	Diarrhoea	Gastrointestinal disorders	Run-in Period: LT4 Tablets	1	47	1
other	Upper respiratory tract infection	Infections and infestations	Treatment Period: Tirosint Capsules	2	47	2
other	Upper respiratory tract infection	Infections and infestations	Run-in Period: LT4 Tablets	1	47	1
other	Nausea	Gastrointestinal disorders	Treatment Period: Tirosint Capsules	1	47	1
other	Nausea	Gastrointestinal disorders	Run-in Period: LT4 Tablets	1	47	1
other	Vomiting	Gastrointestinal disorders	Treatment Period: Tirosint Capsules	1	47	1
other	Vomiting	Gastrointestinal disorders	Run-in Period: LT4 Tablets	1	47	1
other	Fatigue	General disorders	Treatment Period: Tirosint Capsules	0	47	0
other	Fatigue	General disorders	Run-in Period: LT4 Tablets	2	47	2

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment Period: Tirosint Capsules	0	47
Total, all-cause mortality	Run-in Period: LT4 Tablets	0	47
Total, other adverse events	Treatment Period: Tirosint Capsules	13	47
Total, other adverse events	Run-in Period: LT4 Tablets	10	47
Total, serious adverse events	Treatment Period: Tirosint Capsules	1	47
Total, serious adverse events	Run-in Period: LT4 Tablets	2	47

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37885233	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Treatment Period: Tirosint Capsules vs Run-in Period: LT4 Tablets: deaths from any cause	Trial comparisons
Treatment Period: Tirosint Capsules vs Run-in Period: LT4 Tablets: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03094416

GET https://conductscience.org/api/trials/v1/NCT03094416/events?page=2

API reference For AI assistants